Hepatic InsufficiencyPhase 1NCT01111318

Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function

A Phase 1 study testing BI 10773 in people with Hepatic Insufficiency and Healthy, run by Boehringer Ingelheim at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency, Healthy
What is being tested?: BI 10773
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteRomania
Study dates: Jul 2010to Nov 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy males and females. Hepatically impaired male and female subjects. Age: 18 - 75 years, BMI: 18-34 kg/m2 Creatinine clearance >80 mL/min (except for patients with severe hepatic impairment, see exclusion criteria.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Who cannot join

Healthy subjects (group 1)
Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery.
Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min.
Chronic or relevant acute infections.

Show all 42Show fewer

History of allergy/hypersensitivity.
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
Inability to refrain from smoking when confined to the study site on trial days.
Alcohol abuse, drug abuse.
Veins unsuited for iv puncture on either arm.
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities (within 48 hours prior to trial or during the trial).
Any laboratory value outside the reference range that is of clinical relevance.
Inability to comply with dietary regimen of study centre.
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Hepatically impaired subjects (group 2-4):
Decompensated gastrointestinal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
For patients with severe liver impairment (Child-Pugh C): Severe concurrent renal dysfunction (e.g., due to hepato-renal syndrome) and a creatinine clearance <40mL/min.
Relevant gastrointestinal tract surgery.
Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
Chronic or relevant acute infections.
History of allergy/hypersensitivity.
Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial.
Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co-medication known to inhibit or induce P-glycoprotein (such as quinidine, cyclosporine, amiodarone) is not allowed. In dubious cases, a case by case decision will be made after consultation with the sponsor.
Participation in another trial with an investigational drug within 2 months after a multiple dose study or within 1 month after a single dose study.
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day).
Inability to refrain from smoking when confined to the study site on trial days.
Alcohol abuse, Drug abuse.
Blood donation (more than 100 mL within four weeks prior to administration or during the trial).
Excessive physical activities (within 48 hours prior to trial or during the trial).
Clinically relevant laboratory abnormalities.
Inability to comply with dietary regimen of study centre.
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
For female subjects of all groups:
Pregnancy
Positive pregnancy test
No adequate contraception during the study and until 2 months after study completion.
Lactation period.

Trial locations and contacts

1 site in 1 country.

Romania1 site

1245.13.40001 Boehringer Ingelheim Investigational Site
Timișoara

Other trials in Romania

About this study

Official title: Pharmacokinetics, Safety and Tolerability of BI 10773 50 mg Single Dose in Male and Female Subjects With Different Degrees of Liver Impairment (Child-Pugh Classification A, B and C) as Compared to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)

Conditions: Hepatic Insufficiency, Healthy
Being tested: BI 10773
Medical subject headings: Hepatic Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 10773Drug
2 tablets BI 10773 25 mg single dose

Study groups in NCT01111318
Study group	Role	What they receive
BI 10773	Experimental	50 mg single dose Receives: Drug: BI 10773

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum Measured Concentration (Cmax)
Maximum measured concentration of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration

Secondary outcomes (12)

Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Time From Dosing to Maximum Concentration (Tmax)
Time from dosing to maximum concentration of empagliflozin (empa) in plasma.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Terminal Rate Constant (λz)
Terminal rate constant in plasma.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Half-Life (t1/2)
Terminal half-life of empagliflozin (empa) in plasma.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Mean Residence Time (MRTpo)
Mean residence time of empagliflozin (empa) in the body.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Apparent clearance of empagliflozin (empa) in the plasma after extravascular administration.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Apparent volume of distribution during the terminal phase (λz).
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)
Amount of empagliflozin (empa) that is eliminated in urine over the time interval 0 to 96 hours.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))
Fraction of empagliflozin (empa) excreted unchanged in urine from time points 0 to 96 hours.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Renal Clearance After Extravascular Administration (CL R)
Renal clearance of empagliflozin (empa) in plasma after extravascular administration.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Urinary Glucose Excretion (UGE)
Urinary glucose excretion, this endpoint was measured using Ae0-96.
The standard deviation is actually the coefficient of variation.
Measured: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator
Clinically relevant abnormalities for physical examination, vital signs, ECG, clinical laboratory tests and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as Adverse Events (AE).
Measured: Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Nov 2010

First posted27 Apr 2010 (estimated)
Study startJul 2010
Primary completionNov 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01111318
Sponsor's protocol ID: 1245.13
Other IDs: 2009-017202-36, 2009
Status last verified: May 2014
First submitted: 26 Apr 2010
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of BI 10773 50 mg Single Dose in Male and Female Subjects With Different Degrees of Liver Impairment (Child-Pugh Classification A, B and C) as Compared to Male and Female Healthy Subjects (a Non-blinded, Parallel Group Study of Phase I)
ClinicalTrials.gov ID: NCT01111318
Acronym / sponsor ID: 1245.13
Conditions: Hepatic Insufficiency, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Nov 2010 (actual)
First posted: 27 Apr 2010 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 10773	Experimental	Drug: BI 1077350 mg single dose

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Healthy males and females. Hepatically impaired male and female subjects. Age: 18 - 75 years, BMI: 18-34 kg/m2 Creatinine clearance >80 mL/min (except for patients with severe hepatic impairment, see exclusion criteria.
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Key exclusion criteria (42 listed)

Healthy subjects (group 1)
Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
Relevant gastrointestinal tract surgery.
Diseases of the central nervous system or psychiatric disorders or relevant neurological disorders.
History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg, pulse rate < 50 or > 100 1/min.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 107732 tablets BI 10773 25 mg single dose	Drug	BI 10773

Primary outcome

Area Under the Curve 0 to Infinity (AUC0-∞)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity. The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Maximum Measured Concentration (Cmax)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum measured concentration of empagliflozin (empa) in plasma. The standard deviation is actually the coefficient of variation. The 'measured values' show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.

12 secondary outcomes

Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Time From Dosing to Maximum Concentration (Tmax)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration.
Terminal Rate Constant (λz)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal Half-Life (t1/2)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Mean Residence Time (MRTpo)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Apparent Clearance After Extravascular Administration (CL/F)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Amount of Empagliflozin That is Eliminated in Urine (Ae0-96)
Time frame: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Fraction of Empagliflozin Excreted Unchanged in Urine (fe0-96))
Time frame: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Renal Clearance After Extravascular Administration (CL R)
Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration
Urinary Glucose Excretion (UGE)
Time frame: Pre-dose and time intervals 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h, 48-72h and 72-96h after drug administration
Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator
Time frame: Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy	12	12
Mild	8	8
Moderate	8	8
Severe	8	8

Primary outcome: Area Under the Curve 0 to Infinity (AUC0-∞)

Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration. Mean (Standard Deviation). Unit: nmol*h/L

Measure	Healthy n = 12	Mild n = 8	Moderate n = 8	Severe n = 8
Value	10800 (22.6)	13800 (38.6)	16100 (26.2)	19000 (27.1)

Healthy vs Mild: Geometric mean ratio: 123.15 (90% CI 98.89 to 153.36), ANOVA
Healthy vs Moderate: Geometric mean ratio: 146.97 (90% CI 118.02 to 183.02), ANOVA
Healthy vs Severe: Geometric mean ratio: 174.70 (90% CI 140.29 to 217.55), ANOVA

Population analysed: Pharmacokinetic (PK) set included all subjects who were documented to have taken the investigational treatment, who provided at least one observation for at least one primary PK endpoint, without important protocol violations relevant to the evaluation of PK, provided no vomiting occurred at or before two times median tmax.

Primary outcome: Maximum Measured Concentration (Cmax)

Time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration. Mean (Standard Deviation). Unit: nmol/L

Measure	Healthy n = 12	Mild n = 8	Moderate n = 8	Severe n = 8
Value	1370 (33.9)	1430 (36.8)	1660 (26.4)	1970 (22.1)

Healthy vs Mild: Geometric mean ratio: 103.81 (90% CI 82.29 to 130.95), ANOVA
Healthy vs Moderate: Geometric mean ratio: 123.31 (90% CI 97.74 to 155.55), ANOVA
Healthy vs Severe: Geometric mean ratio: 148.41 (90% CI 117.65 to 187.23), ANOVA

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Drug administration until 4 days after drug administration or end-of-study visit, up to 19 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy	0 of 12 (0%)	6 of 12 (50%)	Not reported
Mild	0 of 8 (0%)	0 of 8 (0%)	Not reported
Moderate	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Severe	0 of 8 (0%)	2 of 8 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 10773 in people with Hepatic Insufficiency and Healthy, run by Boehringer Ingelheim at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve 0 to Infinity (AUC0-∞) (time frame: Pre-dose and 20minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h and 96h after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01111318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.